Visit www.brookwood-global.com for further details and to order online GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 10 • ONLINE TRAINING • GCP GCP The Principles of GCP This 30-minute course covers the overarching principles of GCP that are the key requirements to be followed in all clinical trials. It is important for everyone involved in human clinical trials whether commercial or noncommercial. It should be taken in conjunction with the other GCP courses we offer. It is especially suitable for those who do not need to know the detail of their practical implementation presented in Annex 1 and the Appendices of the E6(R3) guideline, such as administrators, coordinators and those in departments outside clinical operations. The course is personalized, interactive and has narrated and read-only options. Valuable e-resources in the course include a Guide to Consent, an Essential GCP book and a copy of the ICH GCP E6(R3) guidelines. For details of packages for training larger groups contact us at info@brookwood-global.com Are you ready for … a GCP inspection? • Online, on-demand inspection readiness training • Personalized, narrated or read-only options • Takes around 35 minutes • Highly interactive • Based on answers to a series of questions relating to inspections • Developed with those experienced in inspections and those who perform them! • Comes with a downloadable self-checklist • The training content addresses a wide range of common questions that are often asked and provides information based on experience, words of advice and practical tips. Risk Management in Clinical Trials In this 60-minute course, we look at the general principles relating to risk management in clinical trials. We utilize relevant regulatory guidance as well as the principles in ICH GCP to help you to understand the risk management process and how this is done. Content includes: • The principles of risk-based management of clinical trials • Who should be involved in a risk assessment? • Why might risks change as the trial progresses? • Identification of ‘Critical to Quality Factors’ • The steps involved in a risk-based approach to clinical trials • Setting Quality Tolerance Levels • Risks at the system and trial level • Risk mitigation • Risk-based monitoring • Case studies • Quick quiz to test knowledge • Glossary of terms. RM
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